K201156 is an FDA 510(k) clearance for the ARTIS pheno (VE2). This device is classified as a Interventional Fluoroscopic X-ray System (Class II - Special Controls, product code OWB).
Submitted by Siemens Medical Solution USA, Inc. (Malvern, US). The FDA issued a Cleared decision on June 29, 2020, 60 days after receiving the submission on April 30, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Interventional Fluoroscopy.
| 510(k) Number | K201156 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2020 |
| Decision Date | June 29, 2020 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | OWB - Interventional Fluoroscopic X-ray System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |
| Definition | Interventional Fluoroscopy |